MAUDE Adverse Event Report: CELSIUS MEDICAL S.L. WARMTOUCH; SYSTEM, THERMAL REGULATING

Model Number	5030810
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient suffered a burn while using a blanket post-operative.It was confirmed that there was no abnormality in the testing related equipment.

• Brand Name: WARMTOUCH
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): CELSIUS MEDICAL S.L.; ctra. de ajalvir, km. 5,200; ajalvir 28864 ; SP 28864
• MDR Report Key: 11055020
• Report Number: 2936999-2020-00947
• Device Sequence Number: 2876315
• Product Code: DWJ
• UDI-Device Identifier: 20884521061795
• UDI-Public: 20884521061795
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K913016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 5030810
• Device Catalogue Number: 5030810
• Device Lot Number: 193540058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other